- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02879123
Early Neurological Clinical Recovery, 3 Months After Endovascular Treatment of an Acute Ischemic Stroke (AVC-endovasc)
Assessment of Patients' Early Neurological Clinical Recovery, 3 Months After Endovascular Treatment of an Acute Ischemic Stroke
This trial aims at collecting standardized data concerning the early neurological clinical recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.
Although this outcome is a major issue of patients' prognosis, it is rarely collected at this stage of their follow-up.
Study Overview
Status
Conditions
Detailed Description
Stroke affects 1 patient every 4 minutes in France, with around 130,000 new patients each year. Early recanalisation is a major prognostic factor and the main therapeutic target in the acute phase of this disease. The recanalisation techniques currently developed are intravenous thrombolysis, intra-arterial thrombolysis and thrombectomy (or embolectomy). These therapies can be combined. Thrombectomy involves endovascular capture of the clot obstructing the intracranial artery.
Recent improvements in thrombectomy techniques have also contributed to the spread of this technique. Neurovascular units include endovascular treatment in their strategy for the early management of acute proximal occlusions of intracranial arteries in almost 1 in 3 cases. This approach is currently the subject of professional agreements. Mechanical thrombectomy has now been validated by studies showing a major reduction (-35%) in the disability associated with severe cerebral infarction and a reduction in mortality, with recanalisation rates ranging from 58 to 72%. This "recanalisation" criterion is of major importance because it largely determines the functional prognosis of patients following a cerebral infarction.
Patients are often followed up in the months following the operation by the neurology department that initially treated them, and in the first few weeks they may be admitted to follow-up care units. As a result, although the clinical outcome at 3 months is a major factor in patient prognosis, this information is rarely available. The aim of this study is to obtain standardised 3-month follow-up data for a large series of patients who have undergone endovascular treatment for stroke.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Raphaël Blanc, MD
- Phone Number: + 33 01 48 03 68 28
- Email: rblanc@for.paris
Study Contact Backup
- Name: Amélie Yavchitz, MD
- Phone Number: +33 01 48 03 64 54
- Email: ayavchitz@for.paris
Study Locations
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Paris, France, 75019
- Recruiting
- Fondation Ophtalmologique Adolphe de Rothschild
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Principal Investigator:
- Raphaël Blanc, MD
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Contact:
- Patrick Vachey, ADM
- Phone Number: +33 1 48 03 64 33
- Email: pvachey@for.paris
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- acute ischemic stroke
- endovascular treatment
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
early neurological clinical recovery
Time Frame: 3 months after endovascular treatment of an acute ischemic stroke
|
modified RANKIN score
|
3 months after endovascular treatment of an acute ischemic stroke
|
Collaborators and Investigators
Investigators
- Principal Investigator: Raphaël Blanc, MD, Fondation Ophtalmologique Adolphe de Rothschild
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBC_2015_19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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